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Recruiting NCT06569615

Efficacy of Extracorporeal Shock Wave Therapy, LASER Therapy and Cryotherapy in Patients Having Sacroiliitis

No phase Interventional Sacroilitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: shock wave therapy, LASER Therapy, Cryotherapy, Exercises.
Who it may be relevant to
Registry conditions: Sacroilitis. Basic parameters: 20 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Extracorporeal Shock Wave Therapy, LASER Therapy and Cryotherapy on PPT, Pain and Functional Disability in Patients Having Sacroiliitis: A Randomized Control Study

Overview

This research aimed to determine the effect of extracorporeal shock wave therapy, LASER therapy and cryotherapy on PPT, Pain and functional disability in patients having Sacroiliitis.

Detailed description

The study will be based on a three-arm parallel group randomized control design. sixty participants of sacroiliitis will be recruited from the Physiotherapy department, at Najran University, K.S.A. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups 1, 2 and 3.

All the participants in first week will receive the ice pack for 15 minutes 3 times a day at the lumbosacral area to reduce inflammation in the area, along with rest to reduce irritation at the lumbosacral area for the first week.

From the 2nd week:

Group 1 will be administered ESWT plus exercise, Group 2 will be administered LASER plus exercise, and Group 3 will be administered cryotherapy and exercise.

Interventions

  • Other shock wave therapy
    All the participants in first week will receive the ice pack for 15 minutes 3 times a day at the lumbosacral area to reduce inflammation in the area, along with rest to reduce irritation at the lumbosacral area for the first week. From the 2nd week: Participants will be given Radial shockwave therapy, (Storz Medical Shock Master MP200 device) for 10 minutes/session, one session/week, for 8 weeks.
  • Other LASER Therapy
    All the participants in first week will receive the ice pack for 15 minutes 3 times a day at the lumbosacral area to reduce inflammation in the area, along with rest to reduce irritation at the lumbosacral area for the first week. From the 2nd week: Participants will be given LASER, (LEVELASER EZ1 EASYONE) over the lumbosacral area for 10 minutes/Session, three session/week, for 8 weeks.
  • Other Cryotherapy
    All the participants in first week will receive the ice pack for 15 minutes 3 times a day at the lumbosacral area to reduce inflammation in the area, along with rest to reduce irritation at the lumbosacral area for the first week. From the 2nd week: Participants will be given Cryotherapy, (Gymna UniphyCryoflow 1000 IR Shock Master ICE-CT device) over the lumbosacral area for 10 minutes/Session, three session/week, for 8 weeks.
  • Other Exercises
    The assigned exercises for all participants will include 1. Bilateral bridging, 2. Knee to chest, 3. Back extension within a pain-free range, 4. Plank, 5. Baby pose stretch, 6. Cat and camel, 7. Bilateral adductor ball squeezes and 8. Stretching exercise (Gluteal /Piriformis stretch, Quads /Hams stretch. The treatment plan involved performing three sets of exercises, with each set comprising 8 to 10 repetitions. 20-30 minutes of exercise session will be conducted three times per week over a span

Primary outcome measures

  • Pain Pressure Threshold (PPT) [Time frame: 8 Weeks]
  • Pain Intensity [Time frame: 8 Weeks]
Secondary outcome measures (1)
  • Functional Disability [Time frame: 8 Weeks]

Eligibility criteria

Inclusion criteria

  • Pain in one or both buttocks, hip pain, thigh pain, or even pain more distal.
  • Patients may report that their pain is worse after sitting for prolonged periods or with rotational movements that will be intensified when bending laterally or backward and
  • Positive outcome in a minimum of three out of five pain-provocation tests (i.e., compression test, distraction test, Faber sign, Gaenslen test, and thigh thrust.
  • Pain close to the posterior superior iliac spine and the patient could point with a single finger to the location of pain (Fortin Finger Test).

Exclusion criteria

  • The Participant who had undergone surgery or experienced significant trauma to the spine, pelvis, lower limb, chest, or abdomen within the past 12 months.
  • The participants with lower extremity musculoskeletal disorders, localized spinal pathology, congenital anomalies of the hip, pelvis, or spine that limited mobility.
  • having a positive straight leg raising test
  • receiving nonsteroidal anti-inflammatory drugs, hormonal therapy, or corticosteroid injections
  • individuals with tumors, fractures. ankylosing spondylitis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Saudi Arabia · 1 center
  • Hashim Ahmed — Najran

Identifiers

NCT: NCT06569615 · 202406-076-021198-048523

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗